MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE DRYSEAL FLEX INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number DSF1233

Device Problem Complete Blockage (1094)

Patient Problem Thromboembolism (2654)

Event Date 12/14/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.Gore® dryseal flex introducer sheaths were used for access.At the point of wound closure, no pulse could be felt in the dorsal artery of the patient's right foot.Angiography confirmed an occlusion in the superficial femoral artery.The guide wire was reinserted into the patient and percutaneous balloon angioplasty was performed by using a 4 mm balloon.After confirming the resumption of blood flow, the procedure was completed.It was reported embolization due to thrombus shift was a possible cause of the occlusion.As well, the state of the patient's superficial femoral artery was poor.

Manufacturer Narrative

H.6.Results code 1: 213: a review of the manufacturing records verified the lot met all pre-release specifications.H.6.Conclusion code 1: 22: according to the gore® dryseal flex sheath instructions for use (ifu) adverse events that may occur and / or require intervention include but are not limited to: embolization (micro or macro with transient or permanent ischemia.

• Brand Name: GORE DRYSEAL FLEX INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11032929
• MDR Text Key: 222314465
• Report Number: 3007284313-2020-01200
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132629961
• UDI-Public: 00733132629961
• Combination Product (y/n): N
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2022
• Device Model Number: DSF1233
• Device Catalogue Number: DSF1233
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 83 YR